Varicose VeinsNCT02304146
Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
An observational study of Varicose Veins, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins
- How many people
- 460 participants
- Where
- 3 sitesNetherlands
- Study dates
- Nov 2014to Oct 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who were randomized and received the allocated treatment UGFS or surgical stripping.
Who may be able to join
- all patients included in previous FOAM study
Who cannot join
- no received informed consent
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Department of Dermatology, Atrium Medical Centre.
Heerlen, Limburg
J.J. van der Kleij, M.D.
- Recruiting
Maastricht UMC+
Maastricht, Limburg, 6202AZ
Yee Lai Lam, M.D.
- Recruiting
Departments of Dermatology and Surgery, Laurentius Hospital
Roermond, Limburg
E de Haan, M.D.
About this study
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.
Read the detailed description
It describes the long-term quality of life (QoL) after ultrasound guided foam sclerotherapy (UGFS) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis.
Recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s.
The initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (GSV) ) as measured by colour flow duplex ultrasound (DUS). DUS findings of the treated proximal GSV were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. Patients in categories 2 and 4 are considered to have reflux.
- Conditions
- Varicose Veins
- Keywords
- Foam, UGFS, Stripping, Incompetence
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High ligation and stripping (surgery) | 6-10 years post classical stripping of the great saphenous vein. | |
| Foam sclerotherapy | 6-10 years post post ultrasound guided foam sclerotherapy of the great saphenous vein. |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term QoL follow-up of patients after UGFS and surgical stripping
Measured: 6-10 years follow-up
Secondary outcomes (4)
Clinical recurrence
Measured: 6-10 years follow-up
Technical recurrence
Vein closure rates
Measured: 6-10 years follow-up
Number of retreatments
Measured: 6-10 years follow-up
Venous Clinical Severity Score change
Measured: 6-10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C.H.A. Wittens, M.D. PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304146
- Sponsor's protocol ID
- 144144
- Status last verified
- Dec 2014
- First submitted
- 11 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.
PubMed 22627969Lam YL, Lawson JA, Toonder IM, Shadid NH, Sommer A, Veenstra M, van der Kleij AMJ, Ceulen RP, de Haan E, Ibrahim F, van Dooren T, Nieman FH, Wittens CHA. Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein. Br J Surg. 2018 May;105(6):692-698. doi: 10.1002/bjs.10762.
PubMed 29652081
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
- ClinicalTrials.gov ID
- NCT02304146
- Acronym / sponsor ID
- 144144
- Conditions
- Varicose Veins
- Keywords
- Foam, UGFS, Stripping, Incompetence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.
Detailed description
It describes the long-term quality of life (QoL) after ultrasound guided foam sclerotherapy (UGFS) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis.
Recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s.
The initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (GSV) ) as measured by colour flow duplex ultrasound (DUS). DUS findings of the treated proximal GSV were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. Patients in categories 2 and 4 are considered to have reflux.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High ligation and stripping (surgery) | – | –6-10 years post classical stripping of the great saphenous vein. |
| Foam sclerotherapy | – | –6-10 years post post ultrasound guided foam sclerotherapy of the great saphenous vein. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were randomized and received the allocated treatment UGFS or surgical stripping.
Key inclusion criteria (1 listed)
- all patients included in previous FOAM study
Key exclusion criteria (1 listed)
- no received informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
long-term QoL follow-up of patients after UGFS and surgical stripping
Time frame: 6-10 years follow-up
4 secondary outcomes
Clinical recurrence
Time frame: 6-10 years follow-up
Technical recurrence
Time frame: 6-10 years follow-up
Number of retreatments
Time frame: 6-10 years follow-up
Venous Clinical Severity Score change
Time frame: 6-10 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Results publication: PubMed 22627969Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.
- Derived from this study: PubMed 29652081Lam YL, Lawson JA, Toonder IM, Shadid NH, Sommer A, Veenstra M, van der Kleij AMJ, Ceulen RP, de Haan E, Ibrahim F, van Dooren T, Nieman FH, Wittens CHA. Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein. Br J Surg. 2018 May;105(6):692-698. doi: 10.1002/bjs.10762.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.H.A. Wittens, M.D. PhD principal investigator
Maastricht UMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by Maastricht University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yee Lai Lam, M.D. (+31433881472, y.lam@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term QoL follow-up of patients after UGFS and surgical stripping (time frame: 6-10 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304146, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.